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Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

This study is currently recruiting participants.
Verified April 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01559207
First received: March 19, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.


Condition
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Plasma nucleosome concentration (ng/ml) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    For cohortes T and P

  • Plasma nucleosome concentration (ng/ml) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    For cohortes T and P

  • Plasma nucleosome concentration (ng/ml) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma nucleosome concentration (ng/ml) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma nucleosome concentration (ng/ml) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma nucleosome concentration (ng/ml) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma nucleosome concentration (ng/ml) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma free DNA concentration (ng/ml) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    For cohortes T and P

  • Plasma free DNA concentration (ng/ml) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    For cohortes T and P

  • Plasma free DNA concentration (ng/ml) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma free DNA concentration (ng/ml) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma free DNA concentration (ng/ml) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma free DNA concentration (ng/ml) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    For cohortes T and Px

  • Plasma free DNA concentration (ng/ml) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    For cohortes T and Px


Secondary Outcome Measures:
  • Hemogram [ Time Frame: baseline ] [ Designated as safety issue: No ]
    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  • Hemogram [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  • Hemogram [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  • Hemogram [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  • Hemogram [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  • Hemogram [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  • Hemogram [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

  • D-dimers (ng/ml) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • D-dimers (ng/ml) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • D-dimers (ng/ml) [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • D-dimers (ng/ml) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • D-dimers (ng/ml) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • D-dimers (ng/ml) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • D-dimers (ng/ml) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • Fibrin monomers (ng/ml) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Fibrin monomers (ng/ml) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fibrin monomers (ng/ml) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • Fibrin monomers (ng/ml) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • Fibrin monomers (ng/ml) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • Fibrin monomers (ng/ml) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • Fibrin monomers (ng/ml) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    cohortes "T" and "Px" only

  • creatininemia (µM/L) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • creatininemia (µM/L) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood Glutamo-oxaloacetate transaminase (UI/L) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • blood Glutamo-oxaloacetate transaminase (UI/L) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood glutamo-pyruvate transaminase (UI/L) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • blood glutamo-pyruvate transaminase (UI/L) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood gamma-glutamyl transaminase (UI/L) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood gamma-glutamyl transaminase (UI/L) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • C reactive protein (mg/l) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • C reactive protein (mg/l) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood fibrinogen (g/l) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • blood fibrinogen (g/l) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

EDTA, CTAD and dry tubes; Biological collection at the Nîmes University Hospital.


Estimated Enrollment: 115
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with VTE
Group "P" is composed of all patients with a history of VTE. Group "Px" is a subgroup of 15 patients from group P. Members of "Px" are randomly selected from "P".
Healthy volunteers
Group "T": 15 healthy volunteers with no history of VTE will be included in this group.

Detailed Description:

The secondary objectives of this study are:

A. To describe, for 15 healthy volunteers with no history of venous thromboembolism (VTE), plasma nucleosome and DNA concentrations.

B. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, plasma nucleosome and DNA concentrations.

C. To compare plasma nucleosome and DNA concentrations between healthy volunteers and VTE patients

D. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, the relationships between classification of VTE and plasma nucleosome concentrations:

  • anatomical classification of VTE: (i)superficial, deep ((ii)distal or (iii)proximal), or (iv)pulmonary embolism
  • circumstantial classification of VTE: (i) triggered, no chronic risk factor; (ii) untriggered, with chronic risk factor; (iii)triggered, with chronic risk factor; (iv) untriggered, no chronic risk factor (idiopathic)

E. To describe, for 100 patients with a history of VTE, the variation in plasma nucleosome concentrations 6 months after the first evaluation

  • according to the above anatomical classification
  • according to the above circumstantial classification
  • according to intercurrent events and treatments

F. To compare the plasma concentrations of nucleosomes and free DNA

G. To evaluate the relationship between plasma nucleosome and free DNA concentrations and:

  • circulating leukocyte populations: total leukocyte count, absolute number of neutrophils, monocytes, lymphocytes
  • markers of coagulation activation: d-dimers, circulating fibrin monomers
  • platelet count
  • patients on antivitamin K: INR, patients receiving heparin: antiXa activity

H. Creation of a biological collection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population is composed of 15 healthy volunteers with no history of VTE (group "T") and 100 patients with VTE (group "P"). Fifteen randomly selected members of group P make up the sub-group "Px".

Criteria

Inclusion Criteria:

  • The patient or volunteer must have given his/her informed and signed consent
  • The patient or volunteer must be insured or beneficiary of a health insurance plan
  • The patient or volunteer is available for 6 months of follow-up

For group "P":

  • patient with a history of VTE

For group "T":

  • healthy volunteer
  • no history of VTE
  • no history of chronic disease
  • no history of neoplastic disease
  • no history of chronic infection
  • not taking anticoagulants, antiplatelet medications
  • no acute disease or infection during the last 2 weeks

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient gave birth in the past three months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559207

Contacts
Contact: Sylvie Bouvier, MD +33.(0)4.66.68.32.11 sylvie.bouvier@chu-nimes.fr
Contact: Carey M Suehs, Ph D +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Sylvie Bouvier, MD            
Sub-Investigator: Michel Dauzat, MD PhD            
Sub-Investigator: Antonia Perez Martin, MD            
Sub-Investigator: Guillaume Cayla, MD            
Sub-Investigator: Jean Christophe Gris, MD PhD            
Sub-Investigator: Eva Cochery-Nouvellon, MD            
Sub-Investigator: Erik Mercier, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Sylvie Bouvier, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01559207     History of Changes
Other Study ID Numbers: LOCAL/2011/SB-02, 2011-A01634-37
Study First Received: March 19, 2012
Last Updated: April 25, 2013
Health Authority: France: Committee for the Protection of Personnes
France: L’Agence nationale de sécurité du médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
nucleosome
plasma nucleosome concentrations
free DNA
plasma free DNA concentrations

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 16, 2013